Photodynamic Bone Stabilization and Drug Delivery Systems

ABSTRACT

Photodynamic bone stabilization and drug delivery systems are disclosed herein. In an embodiment, a photodynamic bone stabilization and drug delivery system of the present disclosure includes an insertion catheter having an inner void for passing at least one light-sensitive liquid, and an inner lumen; an expandable portion releasably engaging a distal end of the insertion catheter, wherein the expandable portion comprises an inner expandable portion in communication with the inner lumen of the insertion catheter and sufficiently designed to maintain a light-sensitive liquid therein; and an outer expandable portion, surrounding the inner expandable portion, sufficiently designed to house and release at least one additive from the outer expandable portion in an outward direction from the inner expandable portion; and a light-conducting fiber sized to pass through the inner lumen of the insertion catheter and into the inner expandable portion for delivering light energy to the light-sensitive liquid.

RELATED APPLICATIONS

This application is a continuation application of U.S. application Ser.No. 13/088,916, filed on Apr. 18, 2011, which claims the benefit of andpriority to U.S. Provisional Patent Application No. 61/357,034, filed onJun. 21, 2010, the entirety of these applications are herebyincorporated herein by reference for the teachings therein.

FIELD

The embodiments disclosed herein relate to minimally invasive orthopedicprocedures, and more particularly to photodynamic bone stabilization anddrug delivery systems for fracture fixation.

BACKGROUND

The basic goal of fracture fixation is to stabilize the fractured bone,to enable fast healing of the injured bone, and to return early mobilityand full function of the injured extremity. Fractures can be treatedconservatively or with external and internal fixation. Complicationsassociated with internal fixation include, but are not limited to,inadequate immobilization of the fractured bone which may develop into anonunion, and the development of deep wound infections, which may causesignificant morbidity.

SUMMARY

Photodynamic bone stabilization and drug delivery systems are disclosedherein. According to aspects illustrated herein, there is provided aphotodynamic bone stabilization and drug delivery system that includesan insertion catheter having an elongated shaft with a proximal end, adistal end, and a longitudinal axis therebetween, the insertion catheterhaving an inner void for passing at least one light-sensitive liquid,and an inner lumen; an expandable portion releasably engaging the distalend of the insertion catheter, wherein the expandable portion comprises:an inner expandable portion fabricated from a non-permeable material,wherein the inner expandable portion is in communication with the innerlumen of the insertion catheter and wherein the inner expandable portionis sufficiently designed to maintain a light-sensitive liquid within theinner expandable portion; and an outer expandable portion, surroundingthe inner expandable portion, sufficiently designed to house and releaseat least one additive from the outer expandable portion in an outwarddirection from the inner expandable portion; and a light-conductingfiber, wherein the light-conducting fiber is sized to pass through theinner lumen of the insertion catheter and into the inner expandableportion for delivering light energy to the light-sensitive liquid.

According to aspects illustrated herein, there is provided aphotodynamic bone stabilization and drug delivery system that includesan insertion catheter having an elongated shaft with a proximal end, adistal end, and a longitudinal axis therebetween, the insertion catheterhaving an inner void for passing at least one light-sensitive liquid,and an inner lumen; an expandable portion releasably engaging the distalend of the insertion catheter, wherein the expandable portion is movablefrom a deflated state to an inflated state when a light-sensitive liquidis delivered to the expandable portion; one ore more surface layersdisposed along an outer surface of the expandable portion, wherein theone or more surface layers are sufficiently designed to release at leastone additive; and a light-conducting fiber, wherein the light-conductingfiber is sized to pass through the inner lumen of the insertion catheterand into the expandable portion for delivering light energy to thelight-sensitive liquid.

According to aspects illustrated herein, there is provided a method forrepairing a fractured bone that includes the steps of delivering to aninner cavity of the fractured bone an expandable portion releasablyengaging a distal end of an insertion catheter, wherein the expandableportion comprises: an inner expandable portion fabricated from anon-permeable material, wherein the inner expandable portion is incommunication with an inner lumen of the insertion catheter and whereinthe inner expandable portion is sufficiently designed to maintain alight-sensitive liquid within the inner expandable portion; and an outerexpandable portion, surrounding the inner expandable portion,sufficiently designed to house and release at least one additive fromthe outer expandable portion in an outward direction from the innerexpandable portion; and infusing a light-sensitive liquid through aninner void of the insertion catheter into the inner expandable portionto move the expandable portion from an initial deflated state to a finalinflated state; inserting a light-conducting fiber into the inner lumenof the insertion catheter; activating the light-conducting fiber so asto cure the light sensitive liquid within the inner expandable portion;delivering at least one additive locally to the fractured bone byreleasing the at least one additive from the outer expandable portion;and releasing the expandable portion from the insertion catheter.

BRIEF DESCRIPTION OF THE DRAWINGS

The presently disclosed embodiments will be further explained withreference to the attached drawings, wherein like structures are referredto by like numerals throughout the several views. The drawings shown arenot necessarily to scale, with emphasis instead generally being placedupon illustrating the principles of the presently disclosed embodiments.

FIG. 1 shows a side view of an embodiment of a proximal end of aphotodynamic bone stabilization and drug delivery system for repairing aweakened or fractured bone according to the present disclosure.

FIGS. 2A-2B show a side view of embodiments of a distal end of aphotodynamic bone stabilization and drug delivery system for repairing aweakened or fractured bone according to the present disclosure. Thedistal end includes an expandable portion (illustrated in an expandedposition) sufficiently designed to stabilize the bone, the expandableportion having an internal through hole that extends past a distalsurface of the expandable portion for local delivery of at least oneadditive to the bone.

FIG. 3A shows a side view of an embodiment of a distal end of aphotodynamic bone stabilization and drug delivery system for repairing aweakened or fractured bone according to the present disclosure. Thedistal end includes an expandable portion (illustrated in an expandedposition) sufficiently designed to stabilize the bone, the expandableportion having an outer surface layer incorporating at least oneadditive for local delivery of the additive to the bone.

FIG. 3B shows a side view of an embodiment of a distal end of aphotodynamic bone stabilization and drug delivery system for repairing aweakened or fractured bone according to the present disclosure. Thedistal end includes an expandable portion (illustrated in an expandedposition) sufficiently designed to stabilize the bone. A separate microporous flexible tube incorporating various additives may be slipped overthe expandable portion for local delivery of the additive to the bone.

FIG. 4A shows a side view of an embodiment of a distal end of aphotodynamic bone stabilization and drug delivery system for repairing aweakened or fractured bone according to the present disclosure. Thedistal end includes an expandable portion (illustrated in an expandedposition) having an inner expandable portion sufficiently designed tostabilize the bone, the inner expandable portion surrounded by an outerexpandable portion sufficiently designed to release at least oneadditive, housed between the inner expandable portion and the outerexpandable portion, locally to the bone.

FIG. 4B shows a side view of an embodiment of the expandable portion ofFIG. 4A.

FIG. 4C is a micrograph showing a micro-perforated surface of the outerexpandable portion of the photodynamic bone stabilization and drugdelivery system of FIG. 4A.

FIG. 4D shows a side view of an embodiment of a distal end of aphotodynamic bone stabilization and drug delivery system for repairing aweakened or fractured bone according to the present disclosure. Thedistal end includes an expandable portion (illustrated in an expandedposition) having an inner expandable portion sufficiently designed tostabilize the bone, the inner expandable portion surrounded by an outerexpandable portion sufficiently designed to release at least oneadditive, housed between the inner expandable portion and the outerexpandable portion, locally to the bone. The expandable portion isconnected to a flexible tube with a port.

FIG. 5 shows a side view of an embodiment of a distal end of aphotodynamic bone stabilization and drug delivery system for repairing aweakened or fractured bone according to the present disclosure. Thedistal end includes an expandable portion (illustrated in an expandedposition) having an outer wall with a porous section.

FIG. 6 shows a side view of an embodiment of a distal end of aphotodynamic bone stabilization and drug delivery system for repairing aweakened or fractured bone according to the present disclosure. Thedistal end includes an expandable portion (illustrated in an expandedposition) having a surface layer incorporating at least one additive.

FIG. 7 shows a side view of an embodiment of a distal end of aphotodynamic bone stabilization and drug delivery system for repairing aweakened or fractured bone according to the present disclosure. Thedistal end includes an expandable portion (illustrated in an expandedposition) having an outer wall with a porous section and a surface layerincorporating at least one additive.

FIGS. 8A-8E illustrate an embodiment of a procedure for repairing aweakened or fractured bone. FIG. 8A is a side view of an embodiment of adistal end of a photodynamic bone stabilization and drug delivery systemfor repairing a weakened or fractured bone positioned within a fracturedbone. The distal end of the expandable portion releaseably engages acatheter. FIG. 8B is a side view of the expandable portion of FIG. 8Aafter a light-sensitive liquid monomer has been added to the expandableportion, causing the expandable portion to inflate. FIG. 8C is a sideview of the expandable portion of FIG. 8A after a light-conducting fiberhas been inserted into the expandable portion to transmit energy toinitiate a curing process. FIG. 8D is a side view of the hardenedexpandable portion of FIG. 8A positioned within the weakened orfractured bone after the catheter has been released. FIG. 8E is a sideview of another embodiment of the hardened expandable portion positionedwithin the weakened or fractured bone after the catheter has beenreleased.

FIG. 9 is a schematic illustration of an embodiment of a kit forphotodynamic bone stabilization and drug delivery of the presentdisclosure.

While the above-identified drawings set forth presently disclosedembodiments, other embodiments are also contemplated, as noted in thediscussion. This disclosure presents illustrative embodiments by way ofrepresentation and not limitation. Numerous other modifications andembodiments can be devised by those skilled in the art which fall withinthe scope and spirit of the principles of the presently disclosedembodiments.

DETAILED DESCRIPTION

The embodiments disclosed herein relate to minimally invasive orthopedicprocedures, and more particularly to photodynamic bone stabilization anddrug delivery systems. In an embodiment, a photodynamic bonestabilization and drug delivery system of the present disclosure is usedin repairing a weakened or fractured bone. In an embodiment, aphotodynamic bone stabilization and drug delivery system of the presentdisclosure is used to deliver at least one additive locally to aweakened or fractured bone. In an embodiment, a photodynamic bonestabilization and drug delivery system of the present disclosure is usedto deliver at least one additive locally to a site of repair, whileallowing the user to alter the rate of delivery, duration of delivery,concentration of at least one additive and number of additives at anytime during the healing process.

In an embodiment, a photodynamic bone stabilization and drug deliverysystem of the present disclosure is used to deliver drugs from outsideof the patient body to a location inside the body, particularly into theintramedullary canal of a bone. In an embodiment, the drugs are sitespecific deliverables. In an embodiment, the drugs are physicianspecified. In an embodiment, a photodynamic bone stabilization and drugdelivery system of the present disclosure includes an externalcommunication port connected to an external drug delivery device, suchas a syringe pump, so that drugs can be delivered to the intramedullarycavity from the external drug delivery device. In an embodiment, thedrugs are held in an external reservoir and are delivered to theimplanted expandable portion of the photodynamic bone stabilization anddrug delivery system by the pump to be released into the intramedullarycanal over a period of time. In an embodiment, the concentration orcombination of drugs delivered to the intramedullary canal can bechanged at any time during the healing process as determined by aphysician. In an embodiment, the external communication port to theintramedullary canal can be disconnected when no longer necessarywithout further disruption or intervention to the intramedullary canal.

In an embodiment, a photodynamic bone stabilization and drug deliverysystem of the present disclosure allows for the delivery of physicianspecified drugs and agents from a site external to the intramedullarycanal into the intramedullary canal. In an embodiment, a photodynamicbone stabilization and drug delivery system of the present disclosureallows for the sustained delivery of physician specified drugs andagents into the intramedullary canal from an external fluid reservoirusing a pump delivery system. In an embodiment, a photodynamic bonestabilization and drug delivery system of the present disclosure is usedto deliver physician specified drugs and agents into the intramedullarycanal from a site external to the intramedullary canal via a conductivecatheter fluidly connected to the system, wherein the conductivecatheter can be disconnected from the system without entering theintramedullary canal. In an embodiment, a photodynamic bonestabilization and drug delivery system of the present disclosure enablessite specific delivery into the intramedullary canal from externallocation of physician specified drugs, agents to treat infection,improve bone growth, or chemotherapy agents.

In an embodiment, a photodynamic bone stabilization and drug deliverysystem of the present disclosure is used to deliver at least oneantibiotic locally to a weakened or fractured bone to prevent or treatan infection in the bone. In an embodiment, a photodynamic bonestabilization and drug delivery system of the present disclosure is usedto deliver at least one bone growth factor locally to a weakened orfractured bone to induce formation of new bone. In an embodiment, aphotodynamic bone stabilization and drug delivery system of the presentdisclosure is used to deliver at least one bisphosphonate locally to aweakened or fractured bone to prevent the loss of bone mass. In anembodiment, a photodynamic bone stabilization and drug delivery systemof the present disclosure is used to deliver at least onechemotherapeutic agent.

In an embodiment, a photodynamic bone stabilization and drug deliverysystem of the present disclosure is used to treat a fracture including,but not limited to, a hand fracture, a wrist fracture, a radiusfracture, an ulna fracture, a clavicle fracture, a metacarpal fracture,a phalanx fracture, a metatarsal fracture, a phalange fracture, a tibiafracture, a fibula fracture, a humerus fracture, and a rib fracture.Long bones are the large bones in the arms and legs, and include thehumerus, the radius/ulna, the femur and the tibia/fibula. In anembodiment, a photodynamic bone stabilization and drug delivery systemof the present disclosure is used to reinforce a fractured long bone. Inan embodiment, a photodynamic bone stabilization and drug deliverysystem of the present disclosure is used to stabilize a fractured longbone in conjunction with anatomic reduction (i.e., proper reorientationof fractured elements to their original position, both relative to oneanother and relative to other adjacent anatomical features).

FIG. 1 shows an embodiment of a proximal end 112 of a flexible insertioncatheter 101 of a photodynamic bone stabilization and drug deliverysystem of the present disclosure for repairing a weakened or fracturedbone. The photodynamic bone stabilization and drug delivery systemincludes a thin-walled, non-compliant, expandable portion (not visiblein FIG. 1) releasably mounted at a distal end of the flexible insertioncatheter 101. The insertion catheter 101 may include one or more innerlumens, such as for passing a light-sensitive liquid or an additive, tothe expandable portion.

In an embodiment, the expandable portion includes a single thin-walled,non-compliant, expandable portion with an internal through hole thatextends past a distal surface of the expandable portion for localdelivery of at least one additive to the bone (see FIG. 2A and FIG. 2B).In an embodiment, the expandable portion includes a single thin-walled,non-compliant, expandable portion having an outer surface layer, theouter surface layer being made from electrospun nanofibers andincorporating at least one additive for local delivery of the additiveto the bone (see FIG. 3A and FIG. 3B). In an embodiment, the expandableportion includes two thin-walled, non-compliant, expandable portions,wherein an inner expandable portion is sufficiently designed tostabilize the bone, and wherein an outer expandable portion sufficientlydesigned to release at least one additive housed between the innerexpandable portion and the outer expandable portion (see FIG. 4A). In anembodiment, the flexible insertion catheter 101 and/or the expandableportion includes one or more radiopaque markers or bands positioned atvarious locations. The one or more radiopaque bands, using radiopaquematerials such as barium sulfate, tantalum, or other materials known toincrease radiopacity, allows a medical professional to view thephotodynamic bone stabilization and drug delivery system usingfluoroscopy techniques.

A proximal end adapter 105 includes at least one arm and at least oneadapter which can be utilized for the infusion and withdrawal of fluidsor as conduits for the introduction of devices (e.g., a light-conductingfiber). In an embodiment, an adapter is a Luer lock. In an embodiment,an adapter is a Tuohy-Borst connector. In an embodiment, an adapter is amulti-functional adapter. FIG. 1 shows a side view of a three armproximal end fitting having three adapters 115, 125, and 135. Adapter115 can accept, for example, a light-conducting fiber. Adapter 125 canaccept, for example, air, cooling fluid, an antibiotic, and a bonegrowth factor. In an embodiment, adapter 125 can accept, for example, acooling medium. In an embodiment, adapter 125 can accept, for example, asolution of antibiotic. In an embodiment, adapter 125 can accept, forexample, a solution of bone growth additive. In an embodiment, adapter125 can accept, for example, pressurizing medium. Adapter 135 canaccept, for example, a syringe housing a light-sensitive liquid. In anembodiment, the light-sensitive liquid is a liquid monomer comprising aninitiator, wherein the initiator is activated when the light-conductingfiber transmits light energy. In an embodiment, the viscosity of thelight-sensitive liquid is about 1000 cP or less. In an embodiment, thelight-sensitive liquid has a viscosity ranging from about 650 cP toabout 450 cP. Low viscosity allows filling of the expandable portionthrough a very small delivery system.

In an embodiment, a syringe housing light-sensitive liquid is attachedto the adapter 135 at the proximal end 112 of the insertion catheter101, and during use of the photodynamic bone stabilization and drugdelivery system, the syringe plunger is pushed, allowing the syringe toexpel the light-sensitive liquid into an inner void 110 (not visible inFIG. 1) of the photodynamic bone stabilization and drug delivery system.As the light-sensitive liquid is expelled through the inner void, itreaches the expandable portion to move the expandable portion from adeflated state to an inflated state. The light-sensitive liquid can beaspirated and reinfused as necessary, allowing for adjustments to theexpandable portion prior to curing of the light-sensitive liquid,wherein curing of the light-sensitive liquid hardens the expandableportion in a desired position to stabilize the fracture. Theseproperties allow a user to achieve maximum fracture reduction prior toactivating a light source and converting the liquid monomer into a hardpolymer.

In an embodiment, a syringe housing at least one additive is attached tothe adapter 125 at the proximal end 112 of the insertion catheter 101,and during use of the photodynamic bone stabilization and drug deliverysystem, the syringe plunger is pushed, allowing the syringe to expel theadditive into the expandable portion.

In an embodiment, the light-sensitive liquid may be provided as a unitdose. As used herein, the term “unit dose” is intended to mean aneffective amount of light sensitive liquid adequate for a singlesession. By way of a non-limiting example, a unit dose of a lightsensitive liquid of the present disclosure for expanding the one or moreinner balloons may be defined as enough light-sensitive liquid to expandthe one or more inner balloons so that the expanded one ore more innerballoons substantially fill the space created by the outer balloon. Thevolume of space created by the outer balloon may vary somewhat from userto user. Thus, a user using a unit dose may have excess light-sensitiveliquid left over. It is desirable to provide enough light-sensitiveliquid that even the above-average user will have an effective amount ofrealignment. In an embodiment, a unit dose of a light-sensitive liquidof the present disclosure is contained within a container. In anembodiment, a unit dose of a light-sensitive liquid of the presentdisclosure is contained in an ampoule. In an embodiment, the expandablemember is sufficiently shaped to fit within a space or a gap in afractured bone. In an embodiment, the light-sensitive liquid can bedelivered under low pressure via a standard syringe attached to theport. The light-sensitive liquid can be aspirated and re-infused asnecessary, allowing for adjustments to the inmost inner balloon or theintermediate inner balloon. These properties allow a user to achievemaximum fracture reduction prior to activating a light source andconverting the liquid monomer into a hard polymer.

In an embodiment, a contrast material may be added to thelight-sensitive liquid and/or inflation fluid without significantlyincreasing the viscosity. Contrast materials include, but are notlimited to, barium sulfate, tantalum, or other contrast materials knownin the art. The light-sensitive liquid can be aspirated and re-infusedas necessary, allowing for thickness adjustments to the one or moreinner balloons prior to activating the light source and converting theliquid monomer into a hard polymer. Low viscosity allows filling of theone or more inner balloons through a very small delivery system.

In an embodiment, a light-conducting fiber communicating light from alight source is introduced into adapter 115 at the proximal end 112 ofthe insertion catheter 101 to pass the light-conducting fiber within aninner lumen 120 (not visible in FIG. 1) of the photodynamic bonestabilization and drug delivery system. In an embodiment, thelight-conducting fiber is an light-conducting fiber Light-conductingfibers may be used in accordance with the present disclosure tocommunicate light from the light source to the remote location.Light-conducting fibers use a construction of concentric layers foroptical and mechanical advantages. The most basic function of a fiber isto guide light, i.e., to keep light concentrated over longer propagationdistances—despite the natural tendency of light beams to diverge, andpossibly even under conditions of strong bending. In the simple case ofa step-index fiber, this guidance is achieved by creating a region withincreased refractive index around the fiber axis, called the fiber core,which is surrounded by the cladding. The cladding may be protected witha polymer coating. Light is kept in the “core” of the light-conductingfiber by total internal reflection. Cladding keeps light traveling downthe length of the fiber to a destination. In some instances, it isdesirable to conduct electromagnetic waves along a single guide andextract light along a given length of the guide's distal end rather thanonly at the guide's terminating face.

In some embodiments of the present disclosure, at least a portion of alength of an light-conducting fiber is modified, e.g., by removing thecladding, in order to alter the direction, propagation, amount,intensity, angle of incidence, uniformity and/or distribution of light.In an embodiment, the light-conducting fiber emits light radially in auniform manner, such as, for example, with uniform intensity, along alength of the light-conducting fiber in addition to or instead ofemitting light from its terminal end/tip. To that end, all or part ofthe cladding along the length of the light-conducting fiber may beremoved. It should be noted that the term “removing cladding” includestaking away the cladding entirely to expose the light-conducting fiberas well as reducing the thickness of the cladding. In addition, the term“removing cladding” includes forming an opening, such as a cut, a notch,or a hole, through the cladding. In an embodiment, removing all or partof the cladding may alter the propagation of light along thelight-conducting fiber. In another embodiment, removing all or part ofthe cladding may alter the direction and angle of incidence of lightexuded from the light-conducting fiber.

The light-conducting fiber can be made from any material, such as glass,silicon, silica glass, quartz, sapphire, plastic, combinations ofmaterials, or any other material, and may have any diameter, as not allembodiments of the present disclosure are intended to be limited in thisrespect. In an embodiment, the light-conducting fiber is made from apolymethyl methacrylate core with a transparent polymer cladding. Thelight-conducting fiber can have a diameter between approximately 0.75 mmand approximately 2.0 mm. In some embodiments, the light-conductingfiber can have a diameter of about 0.75 mm, about 1 mm, about 1.5 mm,about 2 mm, less than about 0.75 mm or greater than about 2 mm as notall embodiments of the present disclosure are intended to be limited inthis respect. In an embodiment, the light-conducting fiber is made froma polymethyl methacrylate core with a transparent polymer cladding. Itshould be appreciated that the above-described characteristics andproperties of the light-conducting fibers are exemplary and not allembodiments of the present disclosure are intended to be limited inthese respects. Light energy from a visible emitting light source can betransmitted by the light-conducting fiber. In an embodiment, visiblelight having a wavelength spectrum of between about 380 nm to about 780nm, between about 400 nm to about 600 nm, between about 420 nm to about500 nm, between about 430 nm to about 440 nm, is used to cure thelight-sensitive liquid.

The light-sensitive liquid remains a liquid monomer until activated bythe light-conducting fiber (cures on demand). Radiant energy from thelight-conducting fiber is absorbed and converted to chemical energy toquickly polymerize the monomer. This cure affixes the expandable portionin an expanded shape. A cure may refer to any chemical, physical, and/ormechanical transformation that allows a composition to progress from aform (e.g., flowable form) that allows it to be delivered through theinner void in the insertion catheter 101, into a more permanent (e.g.,cured) form for final use in vivo. For example, “curable” may refer touncured composition, having the potential to be cured in vivo (as bycatalysis or the application of a suitable energy source), as well as toa composition in the process of curing (e.g., a composition formed atthe time of delivery by the concurrent mixing of a plurality ofcomposition components).

The presently disclosed embodiments provide expandable portions ofphotodynamic bone stabilization and drug delivery systems of the presentdisclosure. It should be understood that any of the expandable portionsdisclosed herein may include one or more radiopaque markers or bands.For example, a radiopaque ink bead may be placed at a distal end of theexpandable portion for alignment of the system during fluoroscopy. Theone or more radiopaque bands and radiopaque ink bead, using radiopaquematerials such as barium sulfate, tantalum, or other materials known toincrease radiopacity, allows a medical professional to view theexpandable portion during positioning to properly position theexpandable during a repair procedure, and allows the medicalprofessional to view the expandable portion during inflation and/ordeflation to properly stabilize and align the fractured bones. In anembodiment, the one or more radiopaque bands permit visualization of anyvoids that may be created by air that gets entrapped in the expandableportion. In an embodiment, the one or more radiopaque bands permitvisualization to preclude the expandable portion from misengaging or notmeeting a bone due to improper inflation to maintain a uniformexpandable/bone interface. In an embodiment, an expandable portion canbe sputter coated with a metal material to provide radiopacity and/orreflectivity. Other biocompatible materials can be used to both increaseradiopacity and reflectivity of the light in the expandable portion toimprove or aid in the curing of the light-sensitive liquid.

It should be understood that an expandable portion disclosed herein maybe round, flat, cylindrical, oval, rectangular or any desired shape fora given application. An expandable portion may be formed of a pliable,resilient, conformable, and strong material, including but not limitedto urethane, polyethylene terephthalate (PET), nylon elastomer and othersimilar polymers. In an embodiment, an expandable portion is constructedout of a PET nylon aramet or other non-consumable materials. In anembodiment, an expandable portion may be formed from a material thatallows the expandable portion to conform to obstructions or curves atthe site of implantation.

An expandable portion disclosed herein is sufficiently designed todeliver additives such as antibiotics, antifungal agents, antimicrobialagents, bisphosphonates, chemotherapeutic agents, growth factors andproteins locally to the site of repair. In an embodiment, such additivesare termed drugs—chemical substance used in the treatment, cure,prevention, or diagnosis of disease or used to otherwise enhancephysical or mental well-being. For example, after a minimally invasivesurgical procedure an infection may develop in a patient, requiring thepatient to undergo antibiotic treatment. At least one antibiotic drugmay be delivered locally from the expandable portion to the inner cavityof the bone to prevent or combat a possible infection (osteomyelitis).Examples of antibiotics include, but are not limited to, erythromycin,ciprofloxacin, augmentin, levofloxacin, clindamycin, cefuroxine,flucloxacillin, vancomycin, Nafcillin, cefazolin, cephalosporin,ceftazidime, ceftriaxone, Cefepime, piperacillin-tazobactam,ticarcillin-clavulanic acid, and ampicillin-sulbactam, metronidazole. Atleast one growth factor may be delivered locally from the expandableportion to the inner cavity of the bone to induce the formation of newbone (osteogenesis). Examples of chemotherapeutic agents include, butare not limited to, taxane (docetaxel), doxorubicin, mitomycin C,valrubicin, epirubicin, thiotepa, interferon alpha and other cytokineswith therapeutic activities. Moreover, chemotherapetuic agents may beselected from anticancer agents, such, as by the way of a non-limitingexample, hypochlorous acid, mitoxantrone, camptothecin, cisplatin,bleomycin, cyclophosphamide, methotrexate, streptozotocin, actinomycinD, vincristine, vinblastine, cystine arabinoside, anthracyclines,alkylative agents, platinum compounds, antimetabolites, nucleosideanalogs, methotrexate, purine and pyrimidine analogs, adriamycin,daunomycin, mitomycin, epirubicin, 5-FU, and aclacinomycin. Examples ofgrowth factors include, but are not limited to, insulin-like growthfactors (IGFs), transforming growth factors-βs (TGFβs) and bonemorphogenetic proteins (BMPs). At least one bisphosphonate may bedelivered locally from the expandable portion to the inner cavity of thebone to prevent the loss of bone mass. In an embodiment, an additive canmean a single additive or a combination of additives.

Additives can be delivered, for example, in solution form, in powderform, encapsulated in nanoparticles (such as liposomes), encapsulated inmicroparticles (such as microspheres, microcapsules and beads), aspolymer-drug compounds, or incorporated/impregnated into a scaffold ofselect shape and size. The solution, powder, nanoparticles,microparticles, compounds and scaffolds are sufficiently designed torelease the additive from the expandable portion at an appropriate timefor a given application. In an embodiment, an additive may be as a unitdose. As used herein, the term “unit dose” of an additive is intended tomean an effective amount of additive adequate to be delivered for agiven amount of time. In an embodiment, the viscosity of the additivesolution is controlled so that sufficient release of the additive at thesite is achieved. In an embodiment, at least one additive may bepressurized to a pressure sufficient to cause the release of the atleast one additive at a desired rate. An additive formulation has adrug-loading sufficient to deliver therapeutic levels of the additive.In an embodiment, the at least one additive is part of a porouspolymer-drug compound selected from the group consisting of a porouspolymer-drug foam, a porous polymer-drug sponge, a porous polymer-drugfabric, a porous polymer-drug sheet, a porous polymer-drug roll, aporous polymer-drug microparticle or a porous polymer-drug non-wovenmaterial. In an embodiment, the porous polymer-drug compound ismanufactured from a thermoplastic material selected from the groupconsisting of Ultra-High Molecular Weight Polyethylene (UHMWPE),High-Density Polyethylene (HDPE), Polypropylene (PP), PTFE, PVDF, EVA,Nylon-6, Polyurethane (PE) and PE/PP Co-polymer. The rate of release andavailability of the additive may be regulated so that the quantity of anadditive which is released at a particular time or at a particular siteis relatively constant and uniform over extended periods of time. Therelease rate of the additive(s) from a formulation can be selected tolast a few hours, a few days, or a few weeks. In an embodiment,additives may be re-filled, if desired. In an embodiment, the additiveis released from a bioerodible, bioresorbable, non-toxic, biocompatiblehydrophilic polymer matrix. The factors influencing the release ofadditive from hydrophilic matrices include viscosity of the polymer,ratio of the polymer to additive, mixtures of polymers, compressionpressure, thickness of the final product, particle size of the additive,pH of the matrix, entrapped air in the final product, molecular size ofthe additive, molecular geometry of the additive, solubility of theadditive, the presence of excipients, and the mode of incorporation ofthese substances.

In an embodiment, the expandable portion has a diameter between about 4mm and about 11 mm. In an embodiment, the expandable portion has alength between 30 mm to 220 mm. In an embodiment, the expandable portionhas a diameter ranging from about 5 mm to about 20 mm. In an embodiment,the expandable portion has a length ranging from about 20 mm to about450 mm. In an embodiment, the expandable portion has a diameter of about4 mm and a length of about 30 mm or about 40 mm. In an embodiment, theexpandable portion has a diameter of about 5 mm and a length of about 30mm, about 40 mm, about 50 mm, about 60 mm, or about 70 mm. In anembodiment, the expandable portion has a diameter of about 6 mm and alength of about 30 mm, about 40 mm, about 50 mm, about 60 mm, about 70mm or about 80 mm. In an embodiment, the expandable portion has adiameter of about 7 mm and a length of about 30 mm, about 40 mm, about50 mm, about 60 mm, about 70 mm, about 80 mm, about 120 mm, about 160mm, about 180 mm, about 200 mm or about 220 mm. In an embodiment, theexpandable portion has a diameter of about 8 mm and a length of about 50mm, about 60 mm, about 70 mm, about 80 mm, about 120 mm, about 160 mm,about 180 mm, about 200 mm or about 220 mm. In an embodiment, theexpandable portion has a diameter of about 9 mm and a length of about120 mm, about 160 mm, about 180 mm, about 200 mm or about 220 mm. In anembodiment, the expandable portion has a diameter of about 11 mm and alength of about 120 mm, about 160 mm, about 180 mm, about 200 mm orabout 220 mm. In an embodiment, the expandable portion has a tapereddiameter of about 11 mm to 8 mm and a length of about 120 mm, about 160mm, about 180 mm, about 200 mm or about 220 mm. In an embodiment, theexpandable portion has a diameter of about 5 mm and a length of about 30mm. In an embodiment, the expandable portion has a diameter of about 5mm and a length of about 40 mm. In an embodiment, the expandable portionhas a diameter of about 6 mm and a length of about 30 mm. In anembodiment, the expandable portion has a diameter of about 6 mm and alength of about 40 mm. In an embodiment, the expandable portion has adiameter of about 6 mm and a length of about 50 mm. In an embodiment,the expandable portion has a diameter of about 7 mm and a length ofabout 30 mm. In an embodiment, the expandable portion has a diameter ofabout 7 mm and a length of about 40 mm. In an embodiment, the expandableportion has a diameter of about 7 mm and a length of about 50 mm. In anembodiment, the expandable portion has a diameter of about 14 mm and alength of about 400 mm. In an embodiment, the expandable portion has adiameter of about 14 mm and a length of about 300 mm. It should beunderstood that an expandable portion disclosed herein by way ofexample, but not of limitation

It should be understood that an expandable portion disclosed hereintypically does not have any valves. One benefit of having no valves isthat the expandable portion may be inflated or deflated as much asnecessary to assist in the fracture reduction and placement. Anotherbenefit of the expandable portion having no valves is the efficacy andsafety of the system. Since there is no communication passage oflight-sensitive liquid to the body there cannot be any leakage of liquidbecause all the liquid is contained within the expandable portion. In anembodiment, a permanent seal is created between the expandable portionthat is both hardened and affixed prior to the insertion catheter beingremoved. The expandable portion may have valves, as all of theembodiments are not intended to be limited in this manner.

In an embodiment, an expandable portion of the present disclosureincludes a surface that is resilient and puncture resistant. In anembodiment, the surface of the expandable portion is substantially evenand smooth. In an embodiment, the surface of the expandable portion isnot entirely smooth and may have some small bumps, riblets orconvexity/concavity along the length. In an embodiment, the surface ofthe expandable portion may have ribs, ridges, bumps or other shapes. Inan embodiment, the expandable portion has a surface comprising ribletsconfigured to break up surface tension. In an embodiment, the expandableportion has a textured surface which provides one or more ridges thatallow grabbing. In an embodiment, abrasively treating the surface of theexpandable portion via chemical etching or air propelled abrasive mediaimproves the connection and adhesion between the surface of theexpandable portion and the bone. The surfacing significantly increasesthe amount of surface area that comes in contact with the bone, whichmay increase friction between the expandable portion and the bone and/ormay increase tissue ingrowth into the expandable portion.

FIG. 2 shows a side view of an embodiment of a distal end 114 of theinsertion catheter 101 of FIG. 1 of a photodynamic bone stabilizationand drug delivery system of the present disclosure. The distal end 114includes an expandable portion 200 (illustrated in an expanded position)sufficiently designed to stabilize a bone and to deliver at least oneadditive locally to the endosteal surface of the bone. In an embodiment,the expandable portion 200 is made from a thin-walled, non-compliantmaterial.

In the embodiment illustrated in FIG. 2A, the inner lumen 220 is aninternal through hole that passes through the longitudinal axis of theflexible insertion catheter 101 and through a distal end 214 of theexpandable portion 200. The through hole 220 is sufficiently designed topass a light-conducting fiber, configured to pass a cooling medium, andconfigured for housing and releasing at least one additive. In anembodiment, the cooling medium is sufficiently designed to cool theexpandable portion 200 during the curing process. In an embodiment, thecooling medium is sufficiently designed to cool the expandable portion200 so that the additive remains stable and does not denature.

In an embodiment, the at least one additive is delivered in solutionform through the through hole 220 and passes out the distal end 214 ofthe expandable portion 200 for local delivery to the endosteal surfaceof the bone. In an embodiment, the at least one additive is delivered inencapsulated form through the through hole 220 and passes out the distalend 214 of the expandable portion 200 for local delivery to theendosteal surface of the bone. In an embodiment, the at least oneadditive is delivered as a polymer-drug compound and positioned withinthe through hole 220 to release the additive out the distal end 214 ofthe expandable portion 200 for local delivery to the endosteal surfaceof the bone. In an embodiment, the at least one additive isincorporated/impregnated in a scaffold positioned within the throughhole 220 to release the additive out the distal end 214 of theexpandable portion 200 for local delivery to the endosteal surface ofthe bone. The polymer-drug compounds and scaffolds provide a mechanismwhereby the rate of release and availability of the additive may beregulated so that the quantity of an additive which is released at aparticular time at the endosteal surface of the bone is relativelyconstant and uniform over extended periods of time.

During an embodiment of a procedure for repairing a weakened tofractured long bone, the expandable portion 200 is positioned betweenbone fragments and light-sensitive liquid is passed through the innervoid 110 of the photodynamic bone stabilization and drug delivery systemuntil it reaches the expandable portion 200 and begins to expand orinflate the expandable portion 200. The expandable portion 200 isinflated in situ with light-sensitive liquid to stabilize and reduce thefracture, which can optionally be performed under fluoroscopy. Becausethe light-sensitive liquid will not cure until illumination with lightfrom the light-conducting fiber, the expandable portion 200 can beinflated and deflated as many times as needed in situ to insure theproper stabilization and reduction of the fracture. Once properpositioning of the expandable portion 200 is determined, thelight-conducting fiber is positioned in the through hole 220 of thephotodynamic bone stabilization and drug delivery system and activated,to deliver output energy directly to the expandable portion 200 whichwill polymerize or cure the light-sensitive liquid and stabilize thebone. During use, there is the potential that the in situ curing processof the light-sensitive liquid can cause one or more areas of theexpandable portion 200 to experience a temperature rise. To prevent atemperature rise from occurring, a cooling medium can be deliveredthrough the through hole 220 concurrently with the light-conductingfiber, so as to cool the expandable portion 200 during the curingprocess. After the curing process, at least one additive, such as anantibiotic, a growth factor and/or a bisphosphonate, can be locallydelivered to the inner cavity of the bone via the through hole 220 inthe expandable portion 200. Additives can be delivered, for example, insolution form, encapsulated in nanoparticles (such as liposomes),encapsulated in microparticles (such as microspheres and microcapsules),as polymer-drug compounds, and incorporated/impregnated into a scaffold.Release of the additive locally to the bone can be immediate orsustained (long-term). Release of the additive locally to the endostealsurface of the bone can last a few hours, a few days, or a few weeks.The expandable portion 200 once hardened, is released from the insertioncatheter 101. In an embodiment, after the expandable portion 200 isreleased, an opening is created at the proximal end of the expandableportion 200 providing an additional site of release of the at least oneadditive from the through hole 220 of the expandable portion 200. In anembodiment, the through hole 220 is connected to a port in the patienthaving the hardened expandable portion 200. In an embodiment, the porthas been implanted, for example, subcutaneously. In an embodiment, theport is attached to the skin. The port is an entry point that can beused for later infusion of additional additives during the healingprocess.

In an embodiment, at least one additive may be delivered to the throughhole 220 of the expandable portion 200 through an inner lumen of theinsertion catheter. In an embodiment, the through hole 220 may beconnected to a flexible tube 270 attached to a port 271 as illustratedin FIG. 2B. The port 271 can include an adapter, such a Luer lock, so asyringe can be connected to the port 271 for infusion of additives bothbefore and after implantation of the expandable portion into the body ofa patient. In an embodiment, the port 271 can be implanted, for example,subcutaneously. In an embodiment, the port 271 is rested on the surfaceof the skin. In an embodiment, the port 271 can be used to refill thethrough hole 220 with additives during the healing process.

FIG. 3A shows a side view of an embodiment of a distal end 114 of aphotodynamic bone stabilization and drug delivery system for repairing aweakened or fractured bone according to the present disclosure. Thedistal end 114 includes an expandable portion 300 (illustrated in anexpanded position) sufficiently designed to stabilize a bone. In anembodiment, the expandable portion 300 is made from a thin-walled,non-compliant material.

In an embodiment, the expandable portion 300 (illustrated in an expandedposition) includes an outer surface layer 330 incorporating at least oneadditive. The outer surface layer 330 may extend along only a section ofthe expandable portion 300 or along the entire length of the expandablesection 300. In an embodiment, the outer surface layer 330 is one whichconforms to the shape of the expandable portion 300, i.e. expands withthe expandable portion 300 when the expandable portion 300 is expandedand contracts when the expandable portion 300 is deflated. In anembodiment, the outer surface layer 330 is made from a polymer.

In an embodiment, the outer surface layer 330 may include pores (notshown) designed to be filled with the at least one additive. The poresin the outer surface layer 330 may be designed such that, when theexpandable portion 300 is collapsed, the pores are closed to effectivelyretain the at least one additive therein. However, when the expandableportion 300 is expanded, the pores are stretched open to enable therelease of the at least one additive from the outer surface layer 330.In another embodiment, the surface of the outer surface layer 330 may becoated with the at least one additive or a matrix containing the atleast one additive. In such an embodiment, when the expandable portion300 is expanded in the medullary cavity of a bone, the outer surfacelayer 330 may come in contact with a surface of the bone to deposit theat least one additive or a matrix containing the at least one additivethereon.

In an embodiment, the outer surface layer 330 is made from electrospunnanofibers. In an embodiment, the diameter of the nanofibers is in therange of about 2 to about 4000 nanometers. In an embodiment, thediameter of the nanofibers is in the range of about 2 to about 3000nanometers, and accordingly a large number of nanofibers is present onthe outer surface 330 of the expandable portion 300. Accordingly, theelectrospun surface constitutes a relatively large reservoir for theadditive compared to the weight of the coated expandable portion 300. Itshould be understood that the term electrospinning comprises a processwherein particles are applied onto a base element which is kept at acertain, preferably constant, electric potential, preferably a negativepotential. The particles emerge from a source which is at another,preferably positive potential. The positive and negative potentials may,for example, be balanced with respect to the potential of a surroundingenvironment, i.e., a room in which the process is being performed. Thepotential of the base element with respect to the potential of thesurrounding atmosphere may be between about −5 and about −30 kV, and thepositive potential of the source with respect to the potential of thesurrounding atmosphere may be between about +5 and about +30 kV, so thatthe potential difference between source and base element is betweenabout 10 and about 60 kV.

Nanofibers produced by an electrospinning method are widely used wherespecific pore characteristics are required. In an embodiment, anexpandable portion having an outer surface layer made from electrospunnanofibers has pores that are resistant to cellular infiltration whileretaining the ability for small molecules, additives, nutrients andwater to pass through. The expandable portion 300 produced by thepresent disclosure may define a plurality of sections along its length.For example, the sections may have different properties, such asdifferent hardness. Such different properties may be arrived at byemploying different fiber-forming materials for different sectionsand/or by changing production parameters, such as voltage of electrodesin the electrospinning process, distance between high-voltage andlow-voltage electrodes, rotational speed of the device (or of a corewire around which the device is manufactured), electrical fieldintensity, corona discharge initiation voltage or corona dischargecurrent.

In order to improve adhering of the electrospun outer surface layer 330to the expandable portion 300, the expandable portion body may becovered by an intermediate polymer layer, such as a Ticoflex™ layer,before it is being coated. For example, the intermediate layer may beformed by dip-coating the expandable portion 300. The intermediate layermay alternatively be formed by a polyurethane or by the polymer which isalso used for the outer surface layer coating 330.

In an embodiment, the outer surface layer 330 of the expandable portion300 may constitute a reservoir to additives. The electrospun portionsthereof constitute reservoirs for holding additives or constitute amatrix polymer source where the additives is either blocked into themolecule chain or adheres to or surrounds the molecule chain. Theexpandable portion 300 disclosed herein may carry any appropriateadditive, including but not limited to antibiotics, growth factors andbisphosphonates. The electrospun fibers form a polymer matrix of one ormore polymers. It should be understood that the outer surface layer 330made from electrospun fibres, i.e. the polymer matrix, needs not to bethe outermost layer of the expandable portion 300, for example a layerof a hydrophilic polymer (e.g. polyacrylic acids (and copolymers),polyethylene oxides, poly(N-vinyl lactams such as polyvinyl pyrrolidone,etc.) may be provided as a coating on the outer surface layer 330(polymer matrix). Alternatively, a barrier layer may be provided ascoating on the outer surface layer 330 (polymer matrix) in order toensure that contact between the polymer matrix and any intramedullarymaterial is delayed until the expandable portion 300 is in place. Thebarrier layer may either be formed of a biodegradable polymer whichdissolves or disintegrates, or the barrier layer may be disintegrateupon inflation of the expandable portion 300.

The additive may be mixed into a liquid substance from which the outersurface layer 330 is manufactured. In another embodiment, theadditive(s) is/are present within the polymer matrix as discretemolecules. Within this embodiment, the additive(s) may be contained inmicroparticles, such as microspheres and microcapsules. Themicroparticles may be biodegradable and may be made from a biodegradablepolymer such as a polysaccharide, a polyamino acid, apoly(phosphorester) biodegradable polymer, a polymers or copolymers ofglycolic acid and lactic acid, a poly(dioxanone), a poly(trimethylenecarbonate) copolymer, or a poly(α-caprolactone) homopolymer orcopolymer. Alternatively, the microparticles may be non-biodegradable,such as amorphous silica, carbon, a ceramic material, a metal, or anon-biodegradable polymer. The microparticles may be in the form ofmicrospheres that encapsulate the additive, such as the antibiotic,growth factor or bisphosphonate.

In an embodiment, a separate micro porous flexible tube incorporatingvarious additives is sufficiently designed to be slipped over anexpandable portion of the present disclosure. FIG. 3B shows anembodiment of a micro porous flexible tube 350 being slid over theexpandable portion 300. Benefits of using the micro porous flexible tube350 include, but are not limited to, the delivery of the additive(s) ata physician-selected location and/or point in time. Providing the microporous flexible tube 350 separately from the expandable portion 300 canenable placement of the tube 350 at any position over the expandableportion 300. In an embodiment, the position of the tube 350 relative tothe site of repair and/or relative to the expandable portion 300 can beadjusted after the implantation of the expandable portion 300. In anembodiment, the position of the tube 350 the expandable portion 300relative to the site of repair can be adjusted, so as to maximize thebenefit of the at least one additive released from tube 350. In anembodiment, the porous tube 350 can be slid over the expandable portion300 while the expandable portion 300 is deflated and the porous tube 350can be expanded by the expansion of the expandable portion 300.

Accordingly, various micro porous flexible tubes having variousproperties or incorporating various additives may be inexpensivelymanufactured and slipped over an expandable portion. The micro porousflexible tube may be formed by providing a core element, such as amandrel, onto which the nanofibers are deposited by electrospinning asthe mandrel is continuously rotated. The micro porous flexible tube maybe formed from a porous fabric FIG. 4A shows a side view of anembodiment of a distal end 114 of a photodynamic bone stabilization anddrug delivery system for repairing a weakened or fractured boneaccording to the present disclosure, in which an expandable portion 400(illustrated in an expanded position) is a double wall balloon, havingan inner wall 401 and an outer wall 403. The inner wall 401 and theouter wall 403 define an inner expandable portion 410 sufficientlydesigned to receive a light sensitive liquid to stabilize the bone, andan outer expandable portion 450 sufficiently designed to house andrelease at least one additive. In an embodiment, the inner expandableportion 410 is surrounded by the outer expandable portion 450. In theembodiment illustrated in FIG. 4A, the inner lumen 120 is sufficientlydesigned to pass a light-conducting fiber which, when activated, curesthe light-sensitive liquid monomer. The inner expandable portion 410includes the inner void 110 between an outer surface of the inner lumen120 and an inner surface of the inner wall 401. The inner void 110 issufficiently designed to be filled with a light sensitive liquid. Theouter expandable portion 450 includes a second inner void 405 between anouter surface of the inner wall 401 and an inner surface 430 of theouter wall 403. The second inner void 405 is sufficiently designed tohouse at least one additive.

In an embodiment, a surface of an expandable balloon portion may betextured. In an embodiment, the outer surface of the inner wall 401 ofthe inner expandable balloon portion 410, the inner surface of the outerwall 403 of the outer expandable balloon portion 450 or both surfacesmay be textured, as illustrated in FIG. 4B. The textured surfaces mayprevent capillary adhesion between the surfaces of the inner wall 401and the outer wall 403 during infusion of a liquid, such as a liquidcarrying an additive. In an embodiment, prevention of capillary adhesionmay facilitate the addition of the additive into the second inner void405. The textured surface may be provide in a form selected from atleast one of bumps, riblets, ribs, ridges or other shapes.

In an embodiment, the inner wall 401 is formed from a non-permeable,pliable, resilient, conformable, compliant, and strong material,including but not limited to urethane, polyethylene terephthalate (PET),nylon elastomer and other similar polymers. In an embodiment, the outerwall 403 is formed from a pliable, resilient, conformable, compliant,and strong material, including but not limited to urethane, polyethyleneterephthalate (PET), nylon elastomer and other similar polymers. Toenable the release of the at least one additive from the second innervoid 405, at least a section of the outer wall 403, referred herein as aporous section 433, has holes or pores 480, extending from an innersurface 430 to an outer surface 432 the outer wall 403, as illustratedin FIG. 4C. In an embodiment, the porous section 433 may be formed froma non-porous polymer and the pores 480 may be made in the outerexpandable portion 450 by, for example, laser drilling, mechanicalpunching, mechanical drilling, ion-bean drilling, using a hot wire orany other conventional method known in the art.

Additionally or alternatively, the porous section 433 may be formed froma porous polymer material. In an embodiment, at least a portion of theouter wall is formed from a porous polymer material. Examples of naturalporous polymers include gelatin, fibrin, collagen, elastin, hyaluronicacid, chondroitin sulfate, dermatan sulfate, heparin sulfate, heparin,cellulose, chitin, chitosan, mixtures or copolymers thereof, or a widevariety of others typically disclosed as being useful in implantablemedical devices. Examples of synthetic porous polymers include silicone,polyurethane, polysulfone, polyethylene, polypropylene, polyamide,polyester, polycarboxylic acids, polyvinylpyrrolidone (PVP), maleicanhydride polymers, polyamides, polyvinyl alcohols (PVA), polyethyleneoxides, polyacrylic acid polymers, polytetrafluoroethylene,polyhydroxyethylmethacrylic acid (pHEMA), polyaminopropylmethacrylamide(pAPMA), polyacrylamido-2-methylpropanesulfonic acid (pAMPS),polyacrylamide, polyacrylic acid, mixtures or copolymers thereof, or awide variety of others typically disclosed as being useful inimplantable medical devices. Additional examples of synthetic porouspolymers include biodegradable synthetic porous polymers, such aspolyglycolic acid, polylactic acid, polydiaxonone, poly(-caprolactone),polyanhydrides, poly(3-hydroxybutyrate), poly(ortho esters), poly(aminoacids), polyiminocarbonates, and mixtures or copolymers thereof. Theporosity of these materials may be varied by known techniques during themanufacturing process. In another embodiment, pores may be made along atleast a portion of the outer wall by, for example, laser drilling,mechanical punching, mechanical drilling, ion-bean drilling, using a hotwire or any other conventional method known in the art.

In one embodiment, as illustrated in FIG. 4B, the porous section 433 mayextend along a section of the outer expandable portion 450.Alternatively, the porous section 433 may extends along the entirelengths of the outer expandable portion 450. The porous section 433, andthe pores 480, may be sufficiently designed to release the at least oneadditive from the second inner void 405 to the endosteal surface of thebone at a pre-determined flow. As used herein, the terms “pre-determinedflow” and “flow” may refer to the rate of flow, profile of flow,distribution of flow along the outer expandable portion 450, the timeperiod over which the at least one additive is delivered or combinationsthereof. To achieve the pre-determined flow of the at least one additivefrom the second inner void 405, the porosity of outer expandable portion450 may be varied by varying the quantity, size and shape of the pores480, as well as the length, position and number of porous sections. Inan embodiment, the size and shape of the pores 480 in the porous section433 may be substantially uniform. In this manner, the flow of the atleast one additive through the porous section 433 may be substantiallyuniform. In another embodiment, a particular region at the site ofimplantation of the expandable portion 400 may require a higherconcentration of the at least one additive than other regions, and thusthe size and shape of the pores 480 in the porous section 433 may besubstantially non-uniform throughout the porous section 433.Alternatively or additionally, the length, position or number of poroussections may be varied circumferentially and axially along the outerexpandable portion 450 to achieve a substantially uniform orsubstantially non-uniform flow of the at least one additive from thesecond inner void 405.

The pores 480 may be of any size and shape as needed to maintain thepre-determined flow of the at least one additive from the outerexpandable portion 450. The pores 480 may be straight or tortuous, andmay be, in various embodiments, oval, circular, or elliptical. The pores480 may range in size from less than 1 mm to several microns indiameter. Hundreds of thousands or even millions of pores 480 of thissize can be placed in the porous section 433. Such a design permits poresize to be precisely controlled, enabling very small amounts of anadditive (e.g., an antibiotic, a bone growth factor or a bisphosphonate)to be infused over an accurately defined area over a selectedtime-frame. In an embodiment, use of the porous section 433 in the outerexpandable portion 450 enables a physician to localize the additive andavoid systemic intravenous administration.

In an embodiment, the pore size of the porous section 433 can becontrolled by using an electrospinning method for the production of theporous section 433. By changing the non-woven geometry (diameter offiber, surface properties of fibers, packing density, thickness of film)the rheology of the fluid flow through the porous section 433 can bechanged. In an embodiment, the porous section 433 having the pores 480may be resistant to cellular infiltration (i.e. a barrier film) thatretains the ability for small molecules, nutrients and water to passthrough.

In an embodiment, a photodynamic bone stabilization and drug deliverysystem of the present disclosure is used to deliver drugs from outsideof the body into the intramedullary canal of a bone. In an embodiment,the drugs are site specific deliverables. In an embodiment, the secondinner void 405 may be connected to a flexible tube 470 attached to aport 471 as illustrated in FIG. 4D. The port 471 can include an adapter,such a Luer lock, so a syringe can be connected to the port 471 forinfusion of additives both before and after implantation of theexpandable portion into the body of a patient. In an embodiment,following the implantation of the expandable portion 400 into themedullary cavity, the port 471 can be implanted, for example,subcutaneously. In an embodiment, following the implantation of theexpandable portion 400 into the medullary cavity, the port 471 is restedon the surface of the skin. In an embodiment, the port 471 can be usedto refill the second inner void 405 of the implanted expandable portion400 with additives during the healing process. In an embodiment,following the implantation of the expandable portion 400 into themedullary cavity, physician specified drugs may be delivered to the tothe second inner void 405 from an external storage reservoir via a pumpconnected to the port 471. In an embodiment, the flexible tube 470 isremovably attached to the second inner void 405, such that, followingthe completion of the physician specified drug treatment, the flexibletube 470 can be detached from the second inner void 405, if so desired,without disruption of the medullary cavity.

FIG. 5 shows a side view of an embodiment of a distal end 114 of aphotodynamic bone stabilization and drug delivery system for repairing aweakened or fractured bone according to the present disclosure. Thedistal end 114 includes an expandable portion 500 (illustrated in anexpanded position) that can be used to deliver at least one additivelocally to a site of interest. In an embodiment, the expandable portion500 is sufficiently designed to be inserted into the medullary cavity ofa bone and to deliver at least one additive to the endosteal surface ofthe bone at a pre-determined flow. In an embodiment, the expandableportion 500 is a single wall balloon made from a thin-walled,non-compliant material. In an embodiment, as illustrated in FIG. 5, theexpandable portion 500 may be a double wall balloon, with propertiessimilar to those of the expandable portion 400. In an embodiment, theexpandable portion 500 may include an inner expandable portion 515sufficiently designed to maintain a first fluid therein and an outerexpandable portion 517, surrounding the inner expandable portion andsufficiently designed to house and release at least one additive.

To enable the release of the at least one additive from the expandableportion 500, at least a section of the outer wall 501, referred hereinas a porous section 533, has pores 580 extending from the inner surface530 to the outer surface 532 of the outer wall 501. The porous section533 may, in some embodiments, extend along a section of the outer wall501, while, in other embodiments, the porous section 533 may extendalong the entire lengths of the outer wall 501. The porous section 533may have properties similar to those of the porous section 433,described as above. In an embodiment, at least one additive may bedelivered to the expandable portion 500 through an inner lumen of theinsertion catheter

In an embodiment, a photodynamic bone stabilization and drug deliverysystem of the present disclosure is used to deliver drugs from outsideof the body into the intramedullary canal of a bone. In an embodiment,the drugs are site specific deliverables. In an embodiment, theexpandable portion 500 may be connected to a flexible tube 570 attachedto a port 571 as illustrated in FIG. 5. The port 571 can include anadapter, such a Luer lock, so a syringe can be connected to the port 571for infusion of additives both before and after implantation of theexpandable portion into the body of a patient. In an embodiment,following the implantation of the expandable portion 500 into themedullary cavity, the port 571 can be implanted, for example,subcutaneously. In an embodiment, following the implantation of theexpandable portion 500 into the medullary cavity, the port 571 is restedon the surface of the skin. In an embodiment, the port 571 can be usedto refill the implanted expandable portion 500 with additives during thehealing process. In an embodiment, following the implantation of theexpandable portion 500 into the medullary cavity, physician specifieddrugs may be delivered to the to the expandable portion 500 from anexternal storage reservoir via a pump connected to the port 571. In anembodiment, the flexible tube 570 is removably attached to theexpandable portion 500, such that, following the completion of thephysician specified drug treatment, the flexible tube 570 can bedetached from the expandable portion 500, if so desired, withoutdisruption of the medullary cavity.

FIG. 6 shows a side view of an embodiment of a distal end 114 of aphotodynamic bone stabilization and drug delivery system for repairing aweakened or fractured bone according to the present disclosure. Thedistal end 114 includes an expandable portion 600 (illustrated in anexpanded position) having an outer wall 610, which defines the innervoid 110. In an embodiment, the expandable portion 600 is made from athin-walled, non-compliant material. The expandable portion 600 issufficiently designed to be inserted into the medullary cavity of a boneand to deliver at least one additive to the endosteal surface of thebone at a pre-determined flow. To that end, the expandable portion 600may include a surface layer 630 incorporating at least one additive. Theouter surface layer 630 may extend along only one or more sections ofthe outer wall 601 or along the entire length of the outer wall 601. Theouter surface layer 630 may have properties similar to those of theouter surface layer 330, as described above. In particular, the outersurface layer 630 may, in an embodiment, include pores (not shown)designed to be filled with the at least one additive. The pores in theouter surface layer 630 may be designed such that, when the expandableportion 600 is collapsed, the pores are closed to effectively retain theat least one additive therein. However, when the expandable portion 600is expanded, the pores 680 are stretched open to enable the release ofthe at least one additive from the outer surface layer 630. In anembodiment, the expandable portion 600 may be expanded by delivering asaline or a similar solution into the inner void 110. In an embodiment,the outer surface layer 630 may be a separate micro porous flexible tubesufficiently designed to be slipped over the expandable portion 600, asdescribed with respect to the embodiment of the photodynamic bonestabilization and drug delivery system of the present disclosureillustrated in FIG. 3B.

FIG. 7 shows a side view of an embodiment of a distal end 114 of aphotodynamic bone stabilization and drug delivery system for repairing aweakened or fractured bone according to the present disclosure. Thedistal end 114 includes an expandable portion 700 (illustrated in anexpanded position) having an outer wall 710, which defines the innervoid 110. In an embodiment, the expandable portion 700 is made from athin-walled, non-compliant material. The expandable portion 700 issufficiently designed to be inserted into the medullary cavity of a boneand to deliver at least one additive to the endosteal surface of thebone at a pre-determined flow. For that reason, in the embodiment shownin FIG. 7, the outer wall 710 may include both a porous section 733 anda outer surface layer 730. The porous section 733 and the outer surfacelayer 730 may have properties similar to those of the porous sections433 and 533 and outer surface layers 330 and 630, respectively. Theporous section 733 and the outer surface layer 730 may be used todeliver the same or different additives.

FIGS. 8A-8D illustrate an embodiment of a procedure for repairing aweakened or fractured bone using a photodynamic bone stabilization anddrug delivery system of the present disclosure. As illustrated in FIG.8A, a procedure for repairing a weakened or fractured bone includespositioning the expandable portion between bone fragments. In anembodiment, the expandable portion spans multiple bone fragments. Oncethe expandable portion is positioned, light-sensitive liquid monomer ispassed through the inner void of the photodynamic bone stabilizationsystem until it reaches the expandable portion and begins to expand orinflate the expandable portion, as shown in FIG. 8B. The expandableportion is inflated in situ with light-sensitive liquid monomer tostabilize and reduce the fracture, which can optionally be performedunder fluoroscopy. Because the light-sensitive liquid monomer will notcure until illumination with light from the light-conducting fiber, theexpandable portion can be inflated and deflated as needed in situ toinsure the proper stabilization and reduction of the fracture. Onceproper positioning of the expandable portion is determined, thelight-conducting fiber is introduced into the inner lumen of theexpandable portion and activated, to deliver output energy to theexpandable portion which will polymerize or cure the light-sensitiveliquid monomer, as shown in FIG. 8C.

FIG. 8D shows the hardened expandable portion positioned within theweakened or fractured bone after the catheter has been released. Atleast one additive (shown as dots) is released from the expandableportion near the endosteal surface of the bone. In an embodiment, theexpandable portion includes a single thin-walled, non-compliant,expandable portion with an internal through hole that extends past adistal surface of the expandable portion for local delivery of at leastone additive to the bone. In an embodiment, the expandable portionincludes a single thin-walled, non-compliant, expandable portion havingan outer surface layer, the outer surface layer being made fromelectrospun nanofibers and incorporating at least one additive for localdelivery of the additive to the bone. In an embodiment, the expandableportion includes two thin-walled, non-compliant, expandable portions,wherein an inner expandable portion is sufficiently designed tostabilize the bone, and wherein an outer expandable portion sufficientlydesigned to release at least one additive housed between the innerexpandable portion and the outer expandable portion. As illustrated inFIG. 8E, in an embodiment, the expandable portion can be connected to aflexible tube 801 that is connected to a port 810. In an embodiment, theport can be implanted, for example, subcutaneously. In an embodiment,the port is attached to the skin 820. The port is an entry point thatcan be used for refilling the expandable portion with additionaladditives during the healing process.

In an embodiment, a method for repairing a fractured bone in a patientusing a photodynamic bone stabilization system sufficiently designed tocontrol temperature rise that may occur during use includes: a minimallyinvasive incision is made through a skin of the patient to expose thefractured bone. The incision may be made at the proximal end or thedistal end of the fractured bone to expose a bone surface. Once the bonesurface is exposed, it may be necessary to retract some muscles andtissues that may be in view of the fractured bone. At least a firstproximal access hole is formed in the fractured bone by drilling orother methods known in the art. The first proximal access hole extendsthrough a hard compact outer layer of the fractured bone into therelatively porous inner or cancellous tissue. For bones with marrow, themedullary material should be cleared from the medullary cavity prior toinsertion of the insertion catheter. Marrow is found mainly in the flatbones such as hip bone, breast bone, skull, ribs, vertebrae and shoulderblades, and in the cancellous material at the proximal ends of the longbones like the femur and humerus. Once the medullary cavity is reached,the medullary material including air, blood, fluids, fat, marrow, tissueand bone debris should be removed to form a void. The void is defined asa hollowed out space, wherein a first position defines the most distaledge of the void with relation to the penetration point on the bone, anda second position defines the most proximal edge of the void withrelation to the penetration site on the bone. The bone may be hollowedout sufficiently to have the medullary material of the medullary cavityup to the cortical bone removed. An introducer sheath may be introducedinto the bone via the first access hole and placed between bonefragments of the bone to cross the location of a fracture. Theintroducer sheath may be delivered into the lumen of the bone andcrosses the location of the break so that the introducer sheath spansmultiple sections of bone fragments. The expandable portion of theinsertion catheter, is delivered through the introducer sheath to thesite of the fracture and spans the bone fragments of the bone. Once theexpandable portion is in place, the guidewire may be removed. Thelocation of the expandable portion may be determined using at least oneradiopaque marker which is detectable from the outside or the inside ofthe bone. Once the expandable portion is in the correct position withinthe fractured bone, the introducer sheath may be removed. A deliverysystem housing a light-sensitive liquid is attached to the proximal endof the insertion catheter. The light-sensitive liquid is then infusedthrough an inner void in the insertion catheter and enters theexpandable portion. This addition of the light-sensitive liquid withinthe expandable portion causes the expandable portion to expand. As theexpandable portion is expanded, the fracture is reduced.

Once orientation of the bone fragments are confirmed to be in a desiredposition, the light-sensitive liquid may be cured within the expandableportion, such as by illumination with a visible emitting light source.In an embodiment, visible light having a wavelength spectrum of betweenabout 380 nm to about 780 nm, between about 400 nm to about 600 nm,between about 420 nm to about 500 nm, between about 430 nm to about 440nm, is used to cure the light-sensitive liquid. In an embodiment, theaddition of the light causes the photoinitiator in the light-sensitiveliquid, to initiate the polymerization process: monomers and oligomersjoin together to form a durable biocompatible crosslinked polymer. In anembodiment, the cure provides complete 360 degree radial andlongitudinal support and stabilization to the fractured bone. After thelight-sensitive liquid has been hardened, the light-conducting fiber canbe removed from the insertion catheter.

An additive, such as an antibiotic, a growth factor and/or abisphosphonate, can be locally delivered to the bone via the expandableportion. In an embodiment, an additive is delivered at a rate calculatednot to increase intramedullary pressure. In an embodiment, such as thatillustrated in the embodiment shown and described with regard to FIG. 2,the additive is delivered to the through hole 220 where it can bereleased (via the distal end) into the intramedullary space of the bone.In an embodiment, such as that illustrated in the embodiment shown anddescribed with regard to FIG. 3, the additive is delivered to theintramedullary space of the bone via the outer surface layer 330. In anembodiment, such as that illustrated in the embodiment shown anddescribed with regard to FIG. 4A, the additive is delivered to theintramedullary space of the bone via the holes 480 in the outerexpandable portion 450.

The expandable portion once hardened, may be released from the insertioncatheter. The hardened expandable portion remains in the fractured bone,and the insertion catheter is removed. In an embodiment, the outersurface of the hardened expandable portion makes contact with thecortical bone.

In an embodiment, the expandable portion 400 placed in the medullarycavity enables local, site specific delivery of physician specifiedadditives to the medullary cavity from outside of the body. In general,local, site-specific delivery requires a lower dosage of drug than ifthe same drug was administered systemically. The local, site-specificdelivery can produce desired effects by achieving sufficiently highconcentration at the target site, while minimizing systemicconcentration of the drug. In an embodiment, the second inner void 405of the photodynamic bone stabilization system of the present disclosuremay be filled with at least one additive, which is delivered locallywithin the medullary cavity following the implantation of thephotodynamic bone stabilization system of the present disclosure intothe medullary cavity.

In an embodiment, a photodynamic bone stabilization and drug deliverysystem of the present disclosure is used to deliver physician specifieddrugs and agents locally into the intramedullary canal from a siteexternal to the intramedullary canal via a conductive catheter fluidlyconnected to an expandable portion of the system, wherein the conductivecatheter can be disconnected from the system without entering theintramedullary canal. In an embodiment, such as illustrated in FIG. 4D,the flexible tube 470 is in fluid communication with the second innercavity 405 at one end and with the port 471 located outside themedullary cavity at the opposite end, such that the at least oneadditive may be delivered to the second inner void 405 from outside theintramedullary canal. In an embodiment, the port 471 is implantedsubcutaneously or on the surface of the patient skin and the at leastone additive may be delivered to the second inner void 405 through thetube 470 from an external drug reservoir by a pump connected to the port471. In an embodiment, the concentration or combination of the at leastone additive delivered to the intramedullary canal from the externalreservoir can be changed at any time during the healing process asdetermined by a physician. In another embodiment, the at least oneadditive in the external reservoir can be refilled to provide sustaineddelivery of the at least one additive to the medullary cavity. In anembodiment, the tube 470 and the port 471 can be disconnected from theexpandable portion 400 when no longer needed without further disruptionor intervention to the intramedullary canal.

In an embodiment, a method for a local delivery of at least oneadditive, such as an antibiotic, a growth factor and/or abisphosphonate, to the medullary cavity of a bone is provided.Initially, an embodiment of the photodynamic bone stabilization systemof the present disclosure, such as the embodiments illustrated in FIG.5, may be positioned in the medullary space of the bone, as describedabove. Once in the medullary cavity of the bone, the at least oneadditive may be locally delivered into the medullary cavity from theexpandable portion 500 through the porous section 533.

In an embodiment, the expandable portion 500 is used to deliverphysician specified drugs and agents locally into the intramedullarycanal from a site external to the intramedullary canal via a conductivecatheter fluidly connected to an expandable portion of the system,wherein the conductive catheter can be disconnected from the systemwithout entering the intramedullary canal. In an embodiment, theflexible tube 570 is in fluid communication with the expandable portion500 at one end and with the port 571 located outside the medullarycavity at the opposite end, such that the at least one additive may bedelivered to the expandable portion 500 from outside the intramedullarycanal. In an embodiment, the port 571 is implanted subcutaneously or onthe surface of the patient skin and the at least one additive may bedelivered to the expandable portion 500 through the tube 570 from anexternal drug reservoir by a pump connected to the port 571. In anembodiment, the concentration or combination of the at least oneadditive delivered to the intramedullary canal from the externalreservoir can be changed at any time during the healing process asdetermined by a physician. In another embodiment, the at least oneadditive in the external reservoir can be refilled to provide sustaineddelivery of the at least one additive to the medullary cavity. In anembodiment, the tube 570 and the port 571 can be disconnected from theexpandable portion 500 when no longer needed without further disruptionor intervention to the intramedullary canal.

In an embodiment, a photodynamic bone stabilization system of thepresent disclosure is sufficiently designed to selectively stiffen anexpandable portion of the system during use. In an embodiment, aphotodynamic bone stabilization system of the present disclosureincludes an expandable portion having a plurality of stiffening members.In an embodiment, the plurality of stiffening members are disposed alongthe length of the expandable portion. In an embodiment, the plurality ofstiffening members are disposed along the length of an outer surface ofthe expandable portion. In an embodiment, the plurality of stiffeningmembers are disposed along the length of an inner surface of theexpandable portion. The stiffening members can be secured to theexpandable portion in a variety of ways. For example and not limitation,the stiffening members can be secured to an adapter, e.g., luer, hub,manifold, or a reinforcement or filler material, or support member.Alternatively, the stiffening members can be secured to the expandableportion by way of an engagement member. In this manner, an engagementmember can be secured to the surface of the expandable portion such thata space or cavity is defined for engaging the stiffening members. In anembodiment, the expandable portion includes a plurality of stiffeningmembers configured to control or vary axial flexibility along a lengthof the expandable portion. In an embodiment, the expandable portionincludes a plurality of stiffening members that can be disposed radiallyand/or axially.

In an embodiment, the stiffening members or metallic pieces may protrudeor extend from the expandable portion such that the metallic piecesextend beyond the diameter of the expandable portion. In an embodiment,stiffening members or metallic pieces may be situated within theexpandable portion such that the diameter of the expandable portion maybe substantially maintained. In an embodiment, stiffening members ormetallic pieces may be integral with the expandable portion such thatthe expandable portion and the stiffening members are contiguous withone another. In an embodiment, stiffening members or metallic pieces maybe attached, coupled, covered, sheathed, or otherwise connected to theexpandable portion. In an embodiment, the stiffening members or metallicpieces may be contiguous with one another so as to form one structurearound the expandable portion. In an embodiment, the stiffening membersor metallic pieces can be separate and distinct so as to form multiplestructures around the expandable portion. In an embodiment, thestiffening members or metallic pieces are circumferentially connected toone another at a distal end and a proximal end forming end plates. In anembodiment, the end plates help maintain the structure of the stiffeningmembers or metallic pieces when the expandable portion is expanded.

In an embodiment, the stiffening members or metallic pieces may alter orchange their configuration under a temperature change. In an embodiment,the metallic pieces expand outwards against the bone at the site offracture. In an embodiment, the metallic pieces can expand to increasethe strength of the hardened expandable portion. In an embodiment, themetallic pieces can contract to increase the strength of the hardenedexpandable portion. In an embodiment, an inner surface of the metallicpieces (those surfaces that are in contact with the externalcircumferential surface of the expandable portion) are polished toincrease internal reflection of the light from the light-conductingfiber. In an embodiment, the metallic pieces are sufficiently designedto be load-bearing shapes. In an embodiment, the metallic pieces have alow profile and can handle large loads. In an embodiment, the metallicpieces may produce a greater amount of force on a large area than asmall area. In an embodiment, the metallic pieces may produce a greateramount of force in a tight or narrow space that in a shallow or openspace.

FIG. 9 is a schematic illustration of an embodiment of a kit 900 forphotodynamic bone stabilization and drug delivery system of the presentdisclosure. The kit 900 includes a unit dose of a light sensitive liquid901; an embodiment of an expandable portion 920, such as the expandableportion 200, 300, 400, 500, 600, or 700, releasably mounted on aninsertion catheter 101, wherein the insertion catheter 101 has an innervoid for passing the light-sensitive liquid 901 to the expandableportion, and one or more inner lumens, such as for passing alight-sensitive liquid 901 or an additive 905. In an embodiment, thelight-sensitive liquid 901 is housed in syringe 903. In an embodiment,the syringe 903 maintains a low pressure during the infusion andaspiration of the light-sensitive liquid 901. In an embodiment, the kit900 further includes a unit dose of at least one additive 905, which canbe provided in a syringe 907. In an embodiment, the expandable portion920 is in fluid communication with a flexible tube 917. The syringe 907may be attached to a port 919 at a proximal end of the flexible tube 917to fill the expandable portion with the additive 905 before or after theimplantation of the expandable portion 920. In an embodiment, additionalone or more additives may be added to the expandable section 920throughout the healing process.

In an embodiment, the kit 900 further includes an optical fiber 911,wherein the optical fiber 911 is sized to pass through the inner lumenof the insertion catheter 101 to guide a light into the expandableportion to illuminate and cure the light-sensitive liquid 901. In anembodiment, an attachment system 913 communicates light energy from alight source 915 to the optical fiber 911. In an embodiment, the lightsource 915 emits frequency that corresponds to a band in the vicinity of390 nm to 770 nm, the visible spectrum. In an embodiment, the lightsource 915 emits frequency that corresponds to a band in the vicinity of410 nm to 500 nm. In an embodiment, the light source 910 emits frequencythat corresponds to a band in the vicinity of 430 nm to 450 nm. In anembodiment, the light-sensitive liquid 901 is a liquid monomerhardenable by visible light energy emitted by the light source 915.

In an embodiment, a photodynamic bone stabilization system of thepresent disclosure includes an insertion catheter having an elongatedshaft with a proximal end, a distal end, and a longitudinal axistherebetween, the insertion catheter having an inner void for passing atleast one light-sensitive liquid, and an inner lumen; an expandableportion releasably engaging the distal end of the insertion catheter,wherein the expandable portion comprises: an inner expandable portionfabricated from a non-permeable material, wherein the inner expandableportion is in communication with the inner lumen of the insertioncatheter and wherein the inner expandable portion is sufficientlydesigned to maintain a light-sensitive liquid within the innerexpandable portion; and an outer expandable portion, surrounding theinner expandable portion, sufficiently designed to house and release atleast one additive from the outer expandable portion in an outwarddirection from the inner expandable portion; and a light-conductingfiber, wherein the light-conducting fiber is sized to pass through theinner lumen of the insertion catheter and into the inner expandableportion for delivering light energy to the light-sensitive liquid.

In an embodiment, a photodynamic bone stabilization system of thepresent disclosure includes an insertion catheter having an elongatedshaft with a proximal end, a distal end, and a longitudinal axistherebetween, the insertion catheter having an inner void for passing atleast one light-sensitive liquid, and an inner lumen; an expandableportion releasably engaging the distal end of the insertion catheter,wherein the expandable portion is movable from a deflated state to aninflated state when a light-sensitive liquid is delivered to theexpandable portion; one ore more surface layers disposed along an outersurface of the expandable portion, wherein the one or more surfacelayers are sufficiently designed to release at least one additive; and alight-conducting fiber, wherein the light-conducting fiber is sized topass through the inner lumen of the insertion catheter and into theexpandable portion for delivering light energy to the light-sensitiveliquid.

In an embodiment, a method for repairing a fractured bone of the presentdisclosure includes the steps of delivering to an inner cavity of thefractured bone an expandable portion releasably engaging a distal end ofan insertion catheter, wherein the expandable portion comprises: aninner expandable portion fabricated from a non-permeable material,wherein the inner expandable portion is in communication with an innerlumen of the insertion catheter and wherein the inner expandable portionis sufficiently designed to maintain a light-sensitive liquid within theinner expandable portion; and an outer expandable portion, surroundingthe inner expandable portion, sufficiently designed to house and releaseat least one additive from the outer expandable portion in an outwarddirection from the inner expandable portion; and infusing alight-sensitive liquid through an inner void of the insertion catheterinto the inner expandable portion to move the expandable portion from aninitial deflated state to a final inflated state; inserting alight-conducting fiber into the inner lumen of the insertion catheter;activating the light-conducting fiber so as to cure the light sensitiveliquid within the inner expandable portion; delivering at least oneadditive locally to the fractured bone by releasing the at least oneadditive from the outer expandable portion; and releasing the expandableportion from the insertion catheter.

All patents, patent applications, and published references cited hereinare hereby incorporated by reference in their entirety. While themethods of the present disclosure have been described in connection withthe specific embodiments thereof, it will be understood that it iscapable of further modification. Furthermore, this application isintended to cover any variations, uses, or adaptations of the methods ofthe present disclosure, including such departures from the presentdisclosure as come within known or customary practice in the art towhich the methods of the present disclosure pertain, and as fall withinthe scope of the appended claims.

What is claimed is:
 1. A photodynamic bone stabilization and drugdelivery system for repairing a fractured bone comprising: an insertioncatheter having an elongated shaft with a proximal end, a distal end,and a longitudinal axis therebetween, the insertion catheter having aninner void for passing at least one light-sensitive liquid, and an innerlumen; an expandable portion releasably engaging the distal end of theinsertion catheter, wherein the expandable portion is movable from adeflated state to an inflated state when the light-sensitive liquid isdelivered to the expandable portion; one or more surface layers disposedalong an outer surface of the expandable portion, wherein the one ormore surface layers are sufficiently designed to release at least oneadditive; and a light-conducting fiber, wherein the light-conductingfiber is sized to pass through the inner lumen of the insertion catheterand into the expandable portion for delivering light energy to thelight-sensitive liquid.
 2. The system of claim 1, wherein thelight-conducting fiber emits light radially in a uniform manner along alength of the light-conducting fiber.
 3. The system of claim 1, whereinthe one or more surface layers include a plurality of pores filled withthe at least one additive.
 4. The system of claim 3, wherein the poresare moveable between a substantially closed position for preventingrelease of the at least one additive when the expandable portion is inthe deflated state to a substantially open position to release the atleast one additive when the expandable portion is in the inflated state.5. A system for delivery of at least one additive to a medullary cavityof a bone comprising: an insertion catheter having an elongated shaftwith a proximal end, a distal end, and a longitudinal axis therebetween,the insertion catheter having one or more inner lumens; an expandableportion releasably engaging the distal end of the insertion catheter,wherein the expandable portion comprises: an inner expandable portionfabricated from a non-permeable material, wherein the inner expandableportion is in communication with an inner lumen of the insertioncatheter and wherein the inner expandable portion is sufficientlydesigned to maintain a first fluid within the inner expandable portion;and an outer expandable portion surrounding the inner expandableportion, wherein the outer expandable portion is sufficiently designedto house and release at least one additive from the outer expandableportion in an outward direction from the inner expandable portion; and atube fluidly connected to the outer expandable portion at a first endand fluidly connected to a port at a second end, such that, followingthe implantation of the outer expandable portion in a medullary cavity,the outer expandable portion can be filled with the at least oneadditive through the port from outside the medullary cavity.
 6. Thesystem of claim 5, further comprising an external pump positionedoutside the medullary cavity and connectable to the port to supply theat least one additive to the outer expandable portion.
 7. The system ofclaim 5, wherein the tube is removably attached to the outer expandableportion, such that the tube can be detached from the outer expandableportion without disruption of the medullary cavity.
 8. A system forrepairing a fractured bone comprising: an insertion catheter having anelongated shaft with a proximal end, a distal end, and a longitudinalaxis therebetween, the insertion catheter having an inner void forpassing at least one light-sensitive liquid, and an inner lumen; anexpandable portion releasably engaging the distal end of the insertioncatheter, wherein the expandable portion comprises: an inner expandableportion in communication with the inner lumen of the insertion catheter,wherein the inner expandable portion is sufficiently designed tomaintain a light-sensitive liquid within the inner expandable portion;and an outer expandable portion, surrounding the inner expandableportion, sufficiently designed to house and release at least oneadditive from the outer expandable portion in an outward direction intoan intramedullary canal of the fractured bone; and a light-conductingfiber, wherein the light-conducting fiber is sized to pass through theinner lumen of the insertion catheter and into the inner expandableportion for delivering light energy to cure the light-sensitive liquidwithin the inner expandable portion.
 9. The system of claim 8, whereinthe outer expandable portion is fabricated from a porous polymer. 10.The system of claim 8, further comprising one or more porous sections inthe outer expandable portion designed to release the at least oneadditive.
 11. The system of claim 10, wherein the one or more poroussections in the outer expandable portion include a plurality of poreshaving sizes and shapes that are substantially non-uniform throughoutthe one or more porous sections.
 12. The system of claim 10, wherein theone or more porous sections include a plurality of pores having sizesand shapes that are substantially uniform throughout the one or moreporous sections.
 13. The system of claim 10, wherein the one or moreporous sections are designed to release the at least one additive fromthe outer expandable portion at a pre-determined flow.
 14. A method forrepairing a fractured bone comprising: delivering to an inner cavity ofthe fractured bone an expandable portion releasably engaging a distalend of an insertion catheter, wherein the expandable portion comprises:an inner expandable portion fabricated from a non-permeable material,wherein the inner expandable portion is in communication with an innerlumen of the insertion catheter and wherein the inner expandable portionis sufficiently designed to maintain a light-sensitive liquid within theinner expandable portion; and an outer expandable portion, surroundingthe inner expandable portion, sufficiently designed to house and releaseat least one first additive from the outer expandable portion in anoutward direction from the inner expandable portion; infusing alight-sensitive liquid through an inner void of the insertion catheterinto the inner expandable portion to move the expandable portion from adeflated state to an inflated state; inserting a light-conducting fiberinto the inner lumen of the insertion catheter; activating thelight-conducting fiber to cure the light sensitive liquid within theinner expandable portion; delivering at least one first additive to thefractured bone by releasing the at least one additive from the outerexpandable portion; and releasing the expandable portion from theinsertion catheter.
 15. The method of claim 14, wherein the expandableportion comprises one or more surface layers disposed on an outersurface of the expandable portion and having a plurality of pores filledwith the at least one first additive.
 16. The method of claim 14,wherein the expandable portion comprises a first inner void forreceiving the light sensitive liquid and a second inner void forreceiving the at least one first additive.
 17. The method of claim 16,wherein at least a section of an outer wall of the second inner void isporous to enable the release of the at least one first additive from thesecond inner void.
 18. The method of claim 14, further comprisingrefilling the outer expandable portion with at least one first additive.19. The method of claim 18, wherein the at least one first additive isrefilled from a pump located outside the fractured bone through a portin fluid communication with the outer expandable portion.
 20. The methodof claim 14, further comprising adding at least one second additive tothe outer expandable portion to release the at least one second additivewithin the fractured bone.